Point-of-Care Focused Cardiac Ultrasound in Assessing the Thoracic Aorta
Recruitment status was Recruiting
Aortic Aneurysm, Thoracic
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Prospective Study on Point-of-Care Focused Cardiac Ultrasound in Assessing for Thoracic Aortic Dimensions, Dilation, and Aneurysm in Correlation With CT Angiogram in Suspected Cases of Pathology|
- Maximal diameter measurements of the proximal ascending aorta by CTA and FOCUS [ Time Frame: during emergency department visit (estimated average 3-6 hours) ] [ Designated as safety issue: No ]Maximal diameter measurements of the ascending thoracic aorta by FOCUS will be compared to CTA. Bland Altman plots with 95% limits of agreement will be used to determine clinical and statistical significance.
- Time to Emergency Department Disposition [ Time Frame: estimated time frame 3-6 hours ] [ Designated as safety issue: No ]Time until an admission or discharge order is placed within the electronic medical record
- Number and percent probabilities of differential diagnosis [ Time Frame: (estimated time frame 0 -3 hrous) ] [ Designated as safety issue: No ]Number and percent probabilities of differential diagnosis will be obtained before and after ultrasound to calculate the informational content provided by the ultrasound and perform additional uncertainty analyses
- Time to diagnostic imaging [ Time Frame: estimated time frame 0-6 hours ] [ Designated as safety issue: No ]Time when diagnostic imaging is performed
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Nonspecific chest pain is frequently encountered in the emergency department. Accounting for over 13,000 deaths annually, aortic aneurysmal disease is a potential cause of chest pain.There are multiple diagnostic imaging modalities in practice to interrogate the thoracic aorta, with the most common being computed tomographic angiography (CTA), trans-thoracic echochardiography (TTE) and trans-esophageal echocardiography (TEE), each with its own advantages and limitations. In the ED setting, point-of-care (POC) focused cardiac ultrasound (FOCUS) is increasingly being used as an adjunct to the emergency physician's (EP) workup of undifferentiated chest pain. Based on prior retrospective data FOCUS and CTA appear to have good agreement. This studies aims to confirm these findings through prospective evaluation
Aim 1: To prospectively compare Point of Care (POC) Focused Cardiac Ultrasound (FOCUS) to thoracic computed tomographic angiography (CTA) in the measurement of ascending aortic dimensions.
Maximal diameter measurements of the ascending thoracic aorta by FOCUS will be compared to CTA. Bland Altman plots with 95% limits of agreement will be used to determine clinical and statistical significance.
Hypothesis: 95% limits of agreement between FOCUS and CTA will be within +/- 5 mm.
Aim 2: To determine the diagnostic accuracy of Point-of-Care Focused Cardiac Ultrasound for the detection of thoracic aortic dilation and aneurysm with computed tomographic angiography as the reference standard
Sensitivity, Specificity and Accuracy of FOCUS will be computed with CTA as the reference standard.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01671618
|Contact: Richard A Taylor, MDfirstname.lastname@example.org|
|United States, Connecticut|
|Yale New Haven Hospital||Recruiting|
|New Haven, Connecticut, United States, 06519|
|Contact: Richard A Taylor, MD 860-402-1276 email@example.com|
|Principal Investigator:||Richard A Taylor, MD||Yale University|